Enoxolone in Major Depression - Biomarker-outcome Relationship

Launched by PHILIPPS UNIVERSITY MARBURG · Oct 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called enoxolone for people with unipolar depression, which is a common type of depression. Researchers want to see if certain biological markers in the body, like levels of specific hormones and inflammation, can help predict how well patients will respond to enoxolone compared to a placebo (a fake treatment that doesn’t contain the active drug). The goal is to understand whether these markers can show if enoxolone is more effective and how changes in these markers relate to improvements in depression symptoms.

To participate in this study, you must have unipolar depression and, if you are a woman, be using contraception. You cannot have certain other mental health conditions or serious medical issues that could complicate your participation, such as uncontrolled diabetes or recent treatments like ketamine. If you join the study, you will receive either enoxolone or a placebo, and researchers will monitor your symptoms and any changes in the biological markers throughout the trial. This research could help improve treatment options for people with depression in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Unipolar Depression
• • in women: Contraceptive means
• Exclusion Criteria:
• • Schizophrenic and delusional disorders
• • Neurological diseases in which central nervous system involvement is known, such as epilepsies, storage diseases; severe mental retardation
• • Internistic diseases of moderate or higher severity, which may make participation in the study risky from a clinical point of view. In particular, multiple systolic blood pressure (measured after at least 5 min supine position) of \> 145 mm Hg as well as hypokalemia (\< 3.5 mmol/l) and clinically relevant ECG changes
• • Poorly controlled diabetes mellitus (HbA1c \> 10)
• • Pregnancy or active desire for pregnancy for the duration of the study
• • Non-consent or inability to consent to the study
• • Treatment with the following substances: spironolactone or eplerenone; systemic glucocorticoids
• • Treatment with ketamine or electroconvulsive therapy in the last 3 months before randomization
• • Acute suicidality
• • Intolerance to licorice preparations or licorice contents.